Prospective Analysis of Restorelle in the Treatment of Uterine Prolapse

Uterine Prolapse Clinical Trial

Official title:

Prospective Analysis of Restorelle in the Treatment of Uterine Prolapse

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT02921451
• Other study ID #: IISP 16-05
• Status: Active, not recruiting
• Phase: N/A
• Start date: August 2016
• Est. completion date: August 2020

Study information

• Verified date: August 2019
• Source: Michigan Institution of Women's Health PC
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

The purpose of this study is to determine the long term performance of Restorelle system for the treatment of uterine prolapse.

Description:

This study is being done to evaluate the performance of the Restorelle system, which uses Smartmesh - an ultra-lightweight mesh for uterine prolapse management. Most patients undergo a hysterectomy i.e. removal of the uterus when they have a prolapse. However, this has often been found to be an unnecessary operation. The investigators are studying the use of the Restorelle mesh system to preserve the uterus when there is a uterine prolapse.

Recruitment information / eligibility

• Status: Active, not recruiting
• Enrollment: 40
• Est. completion date: August 2020
• Est. primary completion date: August 2020
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 18 Years to 90 Years

Eligibility

Inclusion Criteria:

1. Subject is female.

2. Subject is at least 18 years of age.

3. Subjects who have already made the decision to proceed with uterine prolapse surgery using Restorelle Mesh.

4. Subject has uterine prolapse defined by Prolapse Quantification System Assessment (POPQ) score of C -2 or greater.

5. Subject reports a bothersome bulge they can see or feel per Pelvic Floor Distress Inventory Short Form 20 (PFDI-20) question 3, response of 2 or higher (i.e. response of "somewhat", "moderately" or "quite a bit").

6. Subject is willing to provide written informed consent.

7. Subject is willing and able to comply with follow-up regimen.

Exclusion Criteria:

1. Subject is pregnant or intends to become pregnant in the future.

2. Subject has a history of pelvic organ cancer (e.g. uterine, ovarian, bladder or cervical).

3. Subject has undergone any previous repair for pelvic organ prolapse.

4. Subject has undergone a hysterectomy.

5. Subject lacks competency of the English language.

Related Conditions & MeSH terms

• Prolapse
• Uterine Prolapse

Intervention

Device:
• Restorelle Smartmesh
Patients will have surgery using the device, Restorelle Smartmesh, for treatment of uterine prolapse.

Locations

Country	Name	City	State
United States	Advanced Urogynecology of Michigan, P.C.	Dearborn	Michigan

Sponsors (2)

Lead Sponsor	Collaborator
Michigan Institution of Women's Health PC	Coloplast A/S

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Number of patients who present with recurrence of uterine prolapse following surgery as assessed by failing to meet success criteria	Success criteria will be defined through the examination of patient's Prolapse Quantification System Assessment (POPQ) score of C -1 or less and patient's report of bothersome bulge they can see or feel per Pelvic Floor Distress Inventory Short Form 20 (PFDI-20) question 3, response of 0 or 1 (i.e. response of "not at all"). Failure to meet this criteria will be considered recurrence of uterine prolapse.	Within first two years after surgical procedure